- Accountable for development and execution of accurate operational Development Plans, including assuring harmonization across clinical trials/program.
- Assist in the development and writing of clinical Trials/program documents and manuals as appropriate
- Assist in the Clinical Research Organization (CRO) identification and selection process.
- Collaborate with Sr. Management, internal project team and CRO partners, as applicable, to prepare clinical trials/program timelines, budget and key deliverables consistent with departmental and corporate objectives.
- Plan, implement, and manage Phase I-III clinical trials, as necessary.
- Collaborate with Sr. Management to determine clinical supply requirements for clinical trials/program.
- Assist for clinical program/trials implementation including operational feasibility, resource forecast and management.
- Align the CTM, Sr. CTMs, CTS to resource the studies across the trials/program.
- Provide updates and status reports to Sr. Management, as requested.
- Contribute to the hiring plan and staffing activities including efficient on-boarding, training and mentoring of new employees.
- Maintain close collaboration with clinical development, other internal departments and external vendors.
- Maintain and develop Investigator sites and KOLs relationship.
- Provide clear objectives, ongoing feedback and end of performance review for any direct reports.
- Bachelor of Science degree or a degree in a field relevant to a profession in the biopharmaceutical industry.
- Minimum of 5-7 years' experience working in project management and/or clinical operations within the biopharmaceutical industries and/or Clinical Research Organization ('CRO').
- Operational, and direct managerial experience in the planning, executing and reporting of global clinical development trials.
- Experience in program management preferred.
- Must have experience in appropriate therapeutic area; preference in Oncology.
- Proven ability to lead a multi-disciplinary teams.
- Experience in developing effective relationships with key investigators.
- Good knowledge of GCPs, clinical trial design, statistics, regulatory processes, and drug development process.
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Associate Director, Clinical Trial Head - Wilmington, United States - InCyte
Description
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.Job Summary (Primary function)
The Associate Director, Clinical Trial Head is accountable for all aspects of assigned clinical trials/program.
The Associate Director is responsible for program level activities as assigned and is accountable for the day-to day clinical development operational plans in accordance with budget and timelines and with standard operating procedures (SOP), ICH Good Clinical Practices and any other specific country regulations.
Essential Functions of the Job (Key responsibilities)Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact if you have any questions or concerns or would like to exercise your rights.
